# K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Dec 28, 2012 after 242 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930712 (1993). 77 ancestors in all.
20 later devices descend from it; 12 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953111: Corail, Landos, Inc. (1996) Summary page 1.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K080980: Exactech Novation Element Press-Fit Femoral Stems, Exactech, Inc. (2008) Summary page 1.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K093646: Depuy Pinnacle with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005)
- K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem, Howmedica Osteonics Corp. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K0001534: DePuy Pinnacle Acetabular System. Number could not be read
- K101451: Apex Module Hip System Biolox Delta Femoral Head, Omni Life Science, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (2016), 4 descendants of its own
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple) (2024), 2 descendants of its own
- K241690: Logical Liner; World Liner; World Knee Patella (2024), 2 descendants of its own

## Recalls of this device
- Apr 20, 2021 · Class II · Z-1694-2021: Product mislabeled, with the incorrect product inside the package.
- Feb 2, 2018 · Class II · Z-0920-2018: This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may n

## Indications for use
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: *Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis *Inflammatory joint disease including rheumatoid arthritis *Correction of functional defornity including congenital hip dysplasia *Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture *Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemniarthroplasty, surface.replacement, or total replacement Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.

Source page: https://510kreport.com/device/K121297
Methodology: https://510kreport.com/methodology